ETHICLIN PRIVATE LIMITED

In their own words

Company Name: Ethiclin Pvt Ltd Mail Id: [email redacted] Mobile No: [phone redacted] About us: as a pharmaceutical Science and participants/Patient oriented health care company, we endeavor to be a good leader in growing India’s health care system. Mission: To unite Skilled and operational Expertise to enhance the quality of Clinical trial data To give a quality of data to the stakeholders of the company Vision: To provide the quality of data review and monitoring of the clinical trial site To give excellence services to upgrade an IEC/IRB functioning Services: I. Clinical Trials 1. Site Selection Visit 2. Clinical Trial Project management activities 3. Clinical trial Monitoring Services/CRAs 4. Feasibility and questionnaires Forms 5. Paper case report forms II. Institutional Ethics Committee/IRB 1. Assists to Ethics Committee registration/Registration 1. Site Selection Visit: Ethiclin Pvt Ltd provides the Site Selection initially with south India region. It’s an important step in clinical trial startup process. Pre-study visits (site selection visits or site qualification visits (SQVs)) are conducted to determine if the investigator and clinical site have the capability to conduct the study. During this visit, both an investigator and a study coordinator must be available. When applicable, pharmacy staff may also need to be available. The monitor will usually request a tour of the facility and time to discuss the basic fundamentals of the protocol and how that relates to the feasibility of recruiting potential participants. 2. Clinical Trial Project management activities: Ethiclin Pvt Ltd provides project management consultancy services to CRO and Sponsors (i.e. Clinical Research Organization). We have experienced in providing project management services to multinational CROs. As a project manager managed full cycle studies in various therapeutic area like Paediatrics, Cardiology, Nephrology, Critical care studies and Oncology etc. Effective Project Managers are essential for managing the study team and meeting project timelines involved in conducting clinical trials. Ethiclin Pvt Ltd is that provides/facilitate clinical trial related activities to a CRO-Contract research organization, a pharmaceutical company, Biotechnology Company, a medical device company or clinical site 3. Clinical Trail Monitoring/CRAs: Ethiclin provides Monitoring of ongoing and about close out clinical trial documents in a clear way. Ethiclin have a separate Standard operating Procedure for the monitoring of clinical trial documents with secure and confidential way. EthiClin maintains the checklist for the monitoring of clinical trials and same will be shared with authorized persons in Sponsors/CRO and Investigator (if Investigator Initiated). Before visiting the site to monitor our company monitor will fill confidentiality agreement form and proceed further. 4. Feasibility and questionnaires: Getting it right from the start Ethiclin Pvt Ltd in the Feasibility assessments help determine if the Hospital is capable of handling a clinical trial in terms of commitment of resources and it also assists in helping develop a budget. Once an Investigator receives the protocol (or protocol synopsis), the next step is to evaluate the feasibility of actually conducting the study. 5. Paper case report forms: We also design the study specific paper case report form within stipulated timelines as per regulatory body as well protocol. Case report form (CRF) is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data. Though paper CRFs are still used largely, use of electronic CRFs (eCRFS) are gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management and faster database lock etc. III. Ethics Committee: Our Ethiciln team ready to assistance you in the process of getting of Ethics Committee new registration/renewal from the Indian regulatory agency. All Research involving human subjects should be conducted in accordance with three basic ethical principles, which include, • Respect for persons • Beneficence • Justice Ethiclin assists you to get the IEC/IRB registration at your location with stipulated time. Ethiclin assists you to get the IEC/IRB registration at your location with stipulated time. 1. Ethics Committee registration Process-Assistance 2. Ethics Committee Accreditation Process- Assistance 3. Any type of SOPs (like Constitution of an IEC, SAE Reporting, Monitoring, Reviewing of study protocol, archival or any other)

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